Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement

Conditions

Aortic Stenosis

Brief summary

To prove the non-inferiority of TAVR-CMR compared to TAVR-CT to guide TAVR according to clinical efficacy, defined as implantation success based on the VARC-2 criteria.

Detailed description

Study Title: Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement (TAVR-CMR). Coordinating Prinicpal Investigator: Prof. Bernhard Metzler, University Clinic of Internal Medicine III, Cardiology and Angiology, Innsbruck Medical University. Planned Study Period: 2017-2023. Objective: To investigate, for the first time, the non-inferiority of TAVR-CMR to contrast-enhanced computed tomography (TAVR-CT) regarding efficacy and safety end-points. Design: Prospective, randomized, open-label, multi-centre trial. Patients (planned): 270 patients. Diagnosis / Inclusion Criteria: Symptomatic severe aortic stenosis scheduled for TAVR based on a local heart-team decision. Methods: Patients will be randomized in a 1:1 fashion to receive a predefined TAVR-CMR protocol or to receive a standard TAVR-CT protocol within two weeks after inclusion. Main Outcome Measure: Follow-up will be performed at hospital discharge after TAVR and after 6 months. The primary efficacy outcome is device implantation success at discharge. The secondary endpoints are a combined safety endpoint and a combined clinical efficacy endpoint at baseline and at 6 months, as well as a comparison of imaging procedure related variables (see section 5.11.2). Endpoint definitions are based on the updated 2012 VARC-2 consensus document.

Lechner I, Oberhollenzer F, Tiller C, Holzknecht M, Kaser A, Binder RK, Gollmann-Tepeköylü C, Klug G, Mayr A, Bauer A, Metzler B, Reindl M, Reinstadler SJ.

2025-03-131 citations

10.1016/j.jocmr.2025.101882

Cardiac Magnetic Resonance Imaging Versus Computed Tomography to Guide Transcatheter Aortic Valve Replacement: A Randomized, Open-Label, Noninferiority Trial

Martin Reindl, Ivan Lechner, Magdalena Holzknecht, Christina Tiller, Priscilla Fink et al. (20 authors)

Circulation2023-08-2720 citations

10.1161/circulationaha.123.066498

Cardiac magnetic resonance imaging versus computed tomography to guide transcatheter aortic valve replacement: study protocol for a randomized trial (TAVR-CMR).

Klug G, Reinstadler S, Troger F, Holzknecht M, Reindl M, Tiller C, Lechner I, Fink P, Pamminger M, Kremser C, Ulmer H, Bauer A, Metzler B, Mayr A.

2022-09-022 citations

10.1186/s13063-022-06638-6

Interventions

DIAGNOSTIC_TESTTAVR-CMR

CMR protocol for the exact determination of the aortic valve dimensions, valve size and implantation route.

DIAGNOSTIC_TESTTAVR-CT

CT protocol for the exact determination of the aortic valve dimensions, valve size and implantation route.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

No

Inclusion criteria

1. Signed informed consent 2. Severe aortic stenosis according to recent guidelines (aortic valve area ≤ 1.0cm² or aortic valve index ≤ 0.6 cm²/m²) (1) 3. Typical symptoms of severe aortic stenosis like shortness of breath, angina or syncope 4. Patient is evaluated for TAVR

Exclusion criteria

1. Contraindications to perform CMR 2. Contraindications to perform CT 3. Contraindications for TAVR or reduced life expectancy \< 1 year. 4. Known hypersensitivity to CMR or CT contrast agents 5. Childbearing potential or inability to exclude pregnancy 6. Inability to understand and follow study-related instructions 7. Severe renal insufficiency requiring renal replacement therapy 8. Severe hepatic insufficiency (Child-Pugh class B or C) 9. Post organ transplantation 10. Participation in another clinical study

Design outcomes

Primary

Measure	Time frame	Description
The non-inferiority of TAVR-CMR compared to TAVR-CT to guide TAVR according to clinical efficacy, defined as implantation success based on the VARC-2 criteria.	6 months	The primary outcome will be a composite clinical efficacy end-point related to implantation success at hospital discharge, based on the VARC-2 criteria: Absence of procedural mortality AND correct positioning of the prosthetic valve AND intended performance of the prosthetic valve (mean aortic valve gradient \< 20mmHg and no valve regurgitation \> mild)

Countries

Austria

Outcome results

None listed